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Inion ACL Instrumentation
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref INS-9305
by Inion Oy
Identity
- Trade Name
- Inion ACL Instrumentation EUDAMEDInion ACL™ Instrumentation FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Inion ACL Instrumentation EUDAMEDInion Instruments EUDAMEDCannulated drill bit, 10mm FDA UDI
- Model / Reference
- INS-9305 EUDAMED1 FDA UDI
- Description
- Cannulated drill bit, 10mm FDA UDI
Identifiers
- Catalog Number
- INS-9305 FDA UDI
- Primary DI / UDI-DI
- 06438408002649 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408002649 EUDAMED6438408INION-IIA-INSTRUUR EUDAMED
- Secondary DI
- M224INS93059 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Inion ACL Instrumentation by Inion Oy — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438408002649 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06438408002649 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (3)
- EUDAMED 1d8db903-04da-4cfa-91a7-19c39e3ac3ce 61 fields · synced Sep 17, 2026
- EUDAMED 979f4267-e3a7-4a1a-937c-4b999000b765 61 fields · synced May 19, 2026
- FDA UDI 54c1d59d-5395-4a5d-99c5-b60d2148fa6d 34 fields · synced May 30, 2026